Bristol-Myers announces five-year results from Phase 3 CheckMate -067 trial
Bristol-Myers Squibb announced five-year results from the Phase 3 CheckMate -067 clinical trial, which continues to demonstrate improved overall survival with the first-line combination of Opdivo plus Yervoy, versus Yervoy alone, in patients with advanced metastatic melanoma. With a minimum follow-up of 60 months, five-year overall survival rates were 52% for the Opdivo plus Yervoy combination, 44% for Opdivo alone, and 26% for Yervoy alone. The safety profile for Opdivo plus Yervoy was consistent with prior findings, with no new safety signals and no additional treatment-related deaths. At this five-year analysis, treatment-related adverse events were consistent with those previously reported and occurred in 300 patients in the combination group, 271 patients in the Opdivo group, and 268 patients in the Yervoy group; grade 3/4 adverse events occurred in 186, 73, and 86 patients, respectively. The percentage of patients experiencing an objective response remained stable at 58% for Opdivo plus Yervoy, 45% for Opdivo alone, and 19% for Yervoy, while the percentage of patients experiencing a complete response continued to increase, with complete response rates at five years of 22% for Opdivo plus Yervoy, 19% for Opdivo alone, and 6% for Yervoy alone. In addition, the proportion of patients alive and treatment-free was 74% in the Opdivo plus Yervoy group and 58% and 45% for Opdivo alone and Yervoy alone, respectively. Among patients with BRAF-mutant or wild-type tumors, the rate of overall survival at five years was 60% and 48%, respectively, in patients who received Opdivo plus Yervoy; 46% and 43% for Opdivo alone; and 30% and 25% for Yervoy alone. Health-related quality of life continued to be maintained during or following treatment with Opdivo alone or the combination of Opdivo plus Yervoy.